A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 21
- 主要终点
- Concentration of bimekizumab in the breast milk on Day 1
研究概览
简要总结
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Study participant must be at least 18 years of age at the time of signing the informed consent.
- •Study participant is being treated with commercial bimekizumab per locally approved prescribing information and in accordance with her treating physician.
- •Study participant is breastfeeding and intends to breastfeed throughout the Sampling Period.
- •The decision to treat with bimekizumab and to breastfeed is made independently from and prior to the study participant consenting to participate in the study.
- •Study participant must be on bimekizumab treatment for at least 12 weeks after delivery and since starting/restarting/continuing bimekizumab prior to sampling (prior to start of the Sampling Period).
- •A female study participant is eligible to participate if she is not pregnant and does not plan to become pregnant during the study.
排除标准
- •Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
- •The infant has any abnormality noted on physical examination or medical history that, in the opinion of the Investigator, may jeopardize or compromise study participation.
- •Study participant has a history of chronic alcohol or drug abuse within the previous last year.
- •Study participant has history of breast implants, breast augmentation, or breast reduction surgery.
- •Study participant plans a surgical intervention during the Screening Period and Sampling Period or anticipates having surgery while participating in the Sampling Period (does not apply to tubal ligation).
- •Study participant or her infant has participated in another study of an investigational medicinal product (IMP) (and/or an investigational device) within the previous 6 months or is currently participating in another study of an IMP (and/or an investigational device), unless the study is UCB PS0036 or a bimekizumab registry study.
- •Study participant or her infant has previously participated (ie, entered the sampling period) in this study.
研究组 & 干预措施
Bimekizumab
Breastfeeding mothers who are already receiving commercial bimekizumab per locally approved prescribing information and in consultation and agreement with their treating physicians will participate in this study. Study participants will continue receiving commercially available bimekizumab under the care of their treating physician.
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Concentration of bimekizumab in the breast milk on Day 1
时间窗: Day 1
Breast milk samples will be collected predose on Day 1.
Concentration of bimekizumab in the breast milk on Day 2
时间窗: Day 2
Breast milk samples will be collected predose on Day 2.
Concentration of bimekizumab in the breast milk on Day 3
时间窗: Day 3
Breast milk samples will be collected predose on Day 3.
Concentration of bimekizumab in the breast milk on Day 5
时间窗: Day 5
Breast milk samples will be collected predose on Day 5.
Concentration of bimekizumab in the breast milk on Day 7
时间窗: Day 7
Breast milk samples will be collected predose on Day 7.
Concentration of bimekizumab in the breast milk on Day 9
时间窗: Day 9
Breast milk samples will be collected predose on Day 9.
Concentration of bimekizumab in the breast milk on Day 11
时间窗: Day 11
Breast milk samples will be collected predose on Day 11.
Concentration of bimekizumab in the breast milk on Day 13
时间窗: Day 13
Breast milk samples will be collected predose on Day 13.
Concentration of bimekizumab in the breast milk on Day 15
时间窗: Day 15
Breast milk samples will be collected predose on Day 15.
Concentration of bimekizumab in the breast milk on Day 29
时间窗: Day 29
Breast milk samples will be collected predose on Day 29 for mothers on every 4 weeks (Q4W) dosing regimen.
Concentration of bimekizumab in the breast milk on Day 57
时间窗: Day 57
Breast milk samples will be collected predose on Day 57 for mothers on every 8 weeks (Q8W) dosing regimen.
次要结局
- Estimated Infant Dosage of bimekizumab from breast milk(Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57)
- Relative Infant Dose of bimekizumab from breast milk(Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57)
- Treatment-emergent Adverse Events (TEAEs) of the mother from time of informed consent through SFU contact(From time of informed consent up to approximately 17 weeks)